Principal Regulatory Officer / EU; Pharma & Generic Products / Project Manage

Hertfordshire/Flexible, UK
07 May 2024
06 Jun 2024
Regulatory Affairs
Full Time
Experienced (non-manager)
Principal Regulatory Officer / EU; Pharma & Generic Products / Project Manage

Excellent opportunity for a 'top-end' Senior Regulatory Officer, with a background in European Market activity.

This leading Pharma and Generics Company seeks a Principal Regulatory Officer for their European Team; ideally, you will be seasoned in the following processes: CTD/Dossiers for MAA's (Modules 1, 2 and 3); European Procedures: National Submissions/MRP and particularly DCP with knowledge of Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's.

Working knowledge of Generic or Pharma Product experience. Good connections within the EMEA and European Authorities are an advantage. 3 rd Party liaison.

It is generally accepted that this company is a superb organisation to learn and develop new Regulatory skills.

Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.

Prepare Regulatory Strategies (including advising of the Regulatory requirements) for new Marketing Authorisation Applications / Post-approval Submissions.

Be actively involved in due diligence activities including evaluation of Regulatory Strategy and launch timelines, evaluation of risks and Regulatory costs.

Candidates from a Pharma or Generics background in EU Regulatory Registrations and Life-cycle management with over 5 years' experience, and good all-round Regulatory skills should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

An excellent salary package awaits the successful candidate including £55,000-£62,000 basic, 20% bonus and leading benefits. Hertfordshire/North of London Location with flexible/hybrid working.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on 0203 695 9477/07 447 977 330, or by, or apply by clicking Apply Now.